Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000008325
Ethics application status
Approved
Date submitted
8/01/2008
Date registered
10/01/2008
Date last updated
9/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of supplement drinks containing immune enhancing properties in improving outcomes for patients undergoing surgery for gastrointestinal cancer.
Scientific title
Effectiveness of pre-operative immunonutrition in improving outcomes for gastrointestinal (GI) cancer patients. A pilot study.
Secondary ID [1] 283091 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastrointestinal Cancer 2676 0
Condition category
Condition code
Diet and Nutrition 2800 2800 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
3x237ml Tetras of Immunonutrition given orally (Impact Advanced Recovery) on a daily basis for 5 days preoperatively
Intervention code [1] 2418 0
Treatment: Other
Comparator / control treatment
3x Tetras of Isocaloric/Isonitrogenous formula given orally on a daily basis for 5 days preoperatively (2x200ml of 1.5cal per ml formula and 1x237ml of 2cal per ml formula).
Control group
Active

Outcomes
Primary outcome [1] 3688 0
Length of Stay
Timepoint [1] 3688 0
Measured at discharge from surgical admission
Secondary outcome [1] 6224 0
Postoperative complications (mortality, anastomotic leaks, sepsis, wound infection, urinary tract infections, wound dishiscence, ileus, pneumonia, return to theatre, need for Total Parenteral Nutrition (TPN))
Timepoint [1] 6224 0
Retrospectively observed at discharge for the period from date of operation to discharge from surgical admission. This will vary depending on the patient's length of stay.

Eligibility
Key inclusion criteria
Adults undergoing category one surgery for gastrointestinal cancer at St Vincent's Hospital Melbourne
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to give consent or participate in nutrition assessment

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2008
Actual
7/05/2008
Date of last participant enrolment
Anticipated
Actual
19/11/2009
Date of last data collection
Anticipated
Actual
Sample size
Target
45
Accrual to date
Final
42
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2936 0
Self funded/Unfunded
Name [1] 2936 0
Clara Newsome
Country [1] 2936 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital
Address
Nutrition Department
St Vincent's Hospital
PO Box 2900
Fitzroy VIC 3065
Country
Australia
Secondary sponsor category [1] 2650 0
University
Name [1] 2650 0
Sharleen O'Reilly
Address [1] 2650 0
Deakin University School of Exercise and Nutrition Sciences
221 Burwood Hwy
Burwood VIC 3125
Country [1] 2650 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4881 0
St Vincent's Health Human Research Commitee A
Ethics committee address [1] 4881 0
St Vincent' Hospital
PO Box 2900
Fitzroy VIC 3065
Ethics committee country [1] 4881 0
Australia
Date submitted for ethics approval [1] 4881 0
28/11/2007
Approval date [1] 4881 0
31/01/2008
Ethics approval number [1] 4881 0
HREC-A 158/07

Summary
Brief summary
This study aims to identify if patients drinking a special liquid nutrition formular prior to their gut surgery will have improved health outcomes. This special formula contains ingredients that are thought to stimulate the immune system.
Trial website
Trial related presentations / publications
Presentations:
Kennedy E, Newsome CM, Simmance N, O'Reilly S. Pre-Surgical Oral Nutrition Therapy for Gastrointestinal Cancer patients. A randomized controlled intervention study. Oral presentation, AuSPEN Scientific Conference, Melbourne, Australia, 2011.

Newsome CM, Kennedy E, Murray K, O'Reilly S. Preoperative Nutrition Therapy for Gastrointestinal Cancer Patients - Intervention process Analysis. Poster presentation, AuSPEN Scientific Conference, Melbourne, Australia, 2011
Public notes

Contacts
Principal investigator
Name 28277 0
Ms Clara Newsome
Address 28277 0
Nutrition Department St Vincent's Hospital 35 Victoria Parade PO Box 2900 Fitzroy VIC 3065
Country 28277 0
Australia
Phone 28277 0
+61 3 9231 3755
Fax 28277 0
Email 28277 0
clara.newsome@svha.org.au
Contact person for public queries
Name 11434 0
Ms Clara Newsome
Address 11434 0
Nutrition Department
St Vincent's Hospital
35 Victoria Parade
PO Box 2900
Fitzroy VIC 3065
Country 11434 0
Australia
Phone 11434 0
+61 3 9231 3755
Fax 11434 0
Email 11434 0
clara.newsome@svha.org.au
Contact person for scientific queries
Name 2362 0
Dr Sharleen O'Reilly
Address 2362 0
Deakin University School of Exercise and Nutrition Sciences
221 Burwood Hwy
Burwood VIC 3125
Country 2362 0
Australia
Phone 2362 0
+61 3 92446778
Fax 2362 0
Email 2362 0
sharleen.oreilly@deakin.edu.au

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No Supporting Document Provided



Results publications and other study-related documents

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